MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Unspecified Infection (1930); Iatrogenic Source (2498)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

Patient age and patient weight were not available by the journal article authors.Event date is approximated.Date provided is when the journal article was published.Citation: jonathan c.Lau, suzanne e.Kosteniuk, david r.Macdonald, and joseph f.Megyesi.Image-guided ommaya reservoir insertion for intraventricular chemotherapy: a retrospective series.(2018).Acta neurochirurgica.Https://doi.Org/10.1007/s00701-017-3454-z.The exact system information could not be determined as it was not provided.However, the system listed on this form was at the address listed in the article during the time some of the surgeries were completed.Multiple attempts have been made to obtain additional information.No further information provided in the journal article or from the authors.The author could not provide any additional information or insight as he was not at the site when the surgeries were performed.No request for service have been received from the customer regarding these events.No parts have been replaced or returned to the manufacturer for evaluation.Per the journal article, the infection occurred beyond the early post-operative period (more than 1 months post-op) and after intraventricular treatment had been initiated.The system was removed 3 months post-op due to isolated infection on culture.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's image guidance system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.Author indicated there were no catheter malfunction, early infection or death.

Event Description

Use of the navigation system was reported.This is medical device report (mdr) one of three.See 1723170-2018-00534 for the second mdr and 1723170-2018-00535 for the third mdr.This is a retrospective study for the cases occurred from 2000 to 2014.Fifty-five consecutive patients underwent ori by the senior author over the study period (43.5 ± 16.6 years; 40.0% female).Forty-seven of those patients underwent surgery with navigation system.Average age for the patients was 41.8 years old, 26 male and 21 female per table 1.One case of malposition, 2 cases of infection and 2 cases of hemorrhage were reported as complications on table 2 for the patient who underwent surgery with navigation.Author identified two infections requiring removal of the ommaya reservoir identified several months after the initial surgery, both of which were in the navigation group.This complaint was for omm 046 who had system removed due to infection.Per the journal article, the infection occurred beyond the early post-operative period (more than 1 months post-op) and after intraventricular treatment had been initiated.The system was removed 3 months post-op due to isolated infection on culture.In conclusion, use of image guidance resulted in fewer operative complications including fewer catheter malpositions and more single-pass procedures.The results support routine use of intraoperative image guidance for proximal catheter insertion in elective ommaya reservoir placement for intraventricular chemotherapy.

Manufacturer Narrative

Correction: patient age and sex were not provided by journal article author.Based on the article information, there were 26 males and 21 males average age of 41.8 years old.Therefore, male and 42 years old were used.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: koko tyler ; 826 coal creek circle; louisville, CO 80027 ; 7208903200
• MDR Report Key: 7299742
• MDR Text Key: 101056477
• Report Number: 1723170-2018-00533
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 42 YR